A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma: Long-Term Follow-Up

Alessia Bari, Raffaella Marcheselli, Luigi Marcheselli, Maria Isabel Alvarez De Celis, Sacchi Samantha Pozzi, Paola Ferri, Antonio Lazzaro, Alberto Fragasso, S. Neri, Luca Baldini, Angelo Michele Carella, F. Angrilli, Roberto Guariglia, Gabriele Buda, Caterina Stelitano, Stefano Sacchi

Research output: Contribution to journalArticle

Abstract

Single-agent bortezomib (B) has shown activity in heavily pretreated patients with relapsed/refractory indolent lymphoma. On the basis of these findings, we performed a phase II study of B combined with rituximab (R) in patients with relapsed follicular lymphoma (FL). Forty-five patients with fairly good prognostic profiles were enrolled from 2007 to 2011 and received a total of 6 cycles of the B+R combination. The endpoints were the overall response rate (ORR), progression-free survival (PFS), duration of remission (DoR), overall survival (OS), and toxicity evaluation. When considering all the enrolled patients the ORR was 64%. At 5 years, the estimated PFS, DoR, and OS were 34, 49, and 70%, respectively. After excluding the 7 R-naïve patients, the ORR was 58%, with a PFS of 19 months. The most common grade >2 toxicities were thrombocytopenia (18%), peripheral neuropathy (13%), and neutropenia (2%). Our study shows the feasibility, long-term efficacy, and excellent tolerability of the B+R combination. We are aware that our study has specific limitations, such as the small sample size consisting of patients with a relatively good prognostic profile. However, because FL patients will be treated with subsequent chemotherapy regimens, a well-tolerated and effective chemotherapy-free therapy could be considered an additional tool for long-term disease control.

Original languageEnglish
Pages (from-to)7-14
Number of pages8
JournalActa Haematologica
DOIs
Publication statusAccepted/In press - Nov 4 2016

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Follicular Lymphoma
Disease-Free Survival
Drug Therapy
Survival
Feasibility Studies
Peripheral Nervous System Diseases
Bortezomib
Rituximab
Neutropenia
Thrombocytopenia
Sample Size
Lymphoma

Keywords

  • Bortezomib
  • Chemotherapy-free regimen
  • Follicular lymphoma
  • Relapsed/progressive disease
  • Rituximab

ASJC Scopus subject areas

  • Medicine(all)
  • Hematology

Cite this

A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma : Long-Term Follow-Up. / Bari, Alessia; Marcheselli, Raffaella; Marcheselli, Luigi; Alvarez De Celis, Maria Isabel; Pozzi, Sacchi Samantha; Ferri, Paola; Lazzaro, Antonio; Fragasso, Alberto; Neri, S.; Baldini, Luca; Carella, Angelo Michele; Angrilli, F.; Guariglia, Roberto; Buda, Gabriele; Stelitano, Caterina; Sacchi, Stefano.

In: Acta Haematologica, 04.11.2016, p. 7-14.

Research output: Contribution to journalArticle

Bari, A, Marcheselli, R, Marcheselli, L, Alvarez De Celis, MI, Pozzi, SS, Ferri, P, Lazzaro, A, Fragasso, A, Neri, S, Baldini, L, Carella, AM, Angrilli, F, Guariglia, R, Buda, G, Stelitano, C & Sacchi, S 2016, 'A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma: Long-Term Follow-Up', Acta Haematologica, pp. 7-14. https://doi.org/10.1159/000449052
Bari, Alessia ; Marcheselli, Raffaella ; Marcheselli, Luigi ; Alvarez De Celis, Maria Isabel ; Pozzi, Sacchi Samantha ; Ferri, Paola ; Lazzaro, Antonio ; Fragasso, Alberto ; Neri, S. ; Baldini, Luca ; Carella, Angelo Michele ; Angrilli, F. ; Guariglia, Roberto ; Buda, Gabriele ; Stelitano, Caterina ; Sacchi, Stefano. / A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma : Long-Term Follow-Up. In: Acta Haematologica. 2016 ; pp. 7-14.
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AU - Marcheselli, Luigi

AU - Alvarez De Celis, Maria Isabel

AU - Pozzi, Sacchi Samantha

AU - Ferri, Paola

AU - Lazzaro, Antonio

AU - Fragasso, Alberto

AU - Neri, S.

AU - Baldini, Luca

AU - Carella, Angelo Michele

AU - Angrilli, F.

AU - Guariglia, Roberto

AU - Buda, Gabriele

AU - Stelitano, Caterina

AU - Sacchi, Stefano

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N2 - Single-agent bortezomib (B) has shown activity in heavily pretreated patients with relapsed/refractory indolent lymphoma. On the basis of these findings, we performed a phase II study of B combined with rituximab (R) in patients with relapsed follicular lymphoma (FL). Forty-five patients with fairly good prognostic profiles were enrolled from 2007 to 2011 and received a total of 6 cycles of the B+R combination. The endpoints were the overall response rate (ORR), progression-free survival (PFS), duration of remission (DoR), overall survival (OS), and toxicity evaluation. When considering all the enrolled patients the ORR was 64%. At 5 years, the estimated PFS, DoR, and OS were 34, 49, and 70%, respectively. After excluding the 7 R-naïve patients, the ORR was 58%, with a PFS of 19 months. The most common grade >2 toxicities were thrombocytopenia (18%), peripheral neuropathy (13%), and neutropenia (2%). Our study shows the feasibility, long-term efficacy, and excellent tolerability of the B+R combination. We are aware that our study has specific limitations, such as the small sample size consisting of patients with a relatively good prognostic profile. However, because FL patients will be treated with subsequent chemotherapy regimens, a well-tolerated and effective chemotherapy-free therapy could be considered an additional tool for long-term disease control.

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